The Merit WRAPSODY AV Access Efficacy Study (WAVE) (WAVE)
T
Thomas Casciani, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
N/A
477 participants needed
2 Locations
Brief description of study
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODYdovascular Stent Graft for treatment of stenosis or occlusion within the dialysis accessutflow circuit
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Venous Stenosis, Venous Occlusion
-
Age: 18 Years
-
Gender: All
Inclusion Criteria:
- Subject provides written informed consent
- Subject is male or female, with an age ≥ 18 years at date of enrollment.
- Subject is willing to undergo all follow-up assessments.
- Subject has a life expectancy ≥ 12 months.
- Subject is undergoing chronic hemodialysis.
- Subject has either a mature AVF or AVG in the arm.
- Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
- Target lesion has ≥50% stenosis.
- Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm
Exclusion Criteria:
- Subject has a known or suspected infection of the hemodialysis access site, systemicd/or septicemia.
- Subject has a stroke diagnosis within 3 months prior to enrollment.
- Subject has a history of unstable angina or myocardial infarction within 60 days prior.
- Subject is pregnant, breastfeeding, or intending to become pregnant within the nextyear.
- Target lesion is located within a stent / stent graft.
Updated on
01 Aug 2024.
Study ID: CVO-P3-20-01
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